GUEST CONTRIBUTORS

  • Supreme Court Biosimilar Decision — What Developers Need To Know
    Supreme Court Biosimilar Decision — What Developers Need To Know

    When the U.S. Supreme Court granted certiorari in the Sandoz v. Amgen litigation earlier this year, many were hoping for a decision that would clarify some key issues pertaining to the requirements of the BPCIA. But the decision left a number of questions unanswered.

  • How To Establish An Aseptic Gowning Qualification Program
    How To Establish An Aseptic Gowning Qualification Program

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.

  • Is Blockchain The Solution To Drug Traceability?
    Is Blockchain The Solution To Drug Traceability?

    It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.

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PHARMA OUTSOURCING WHITE PAPERS

Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions Accelerate Flavivirus Vaccine Production With Modern Tools And Solutions

This white paper gives an overview of modern tools and solutions, adding flexibility and speed to both upstream and downstream operations in flavivirus vaccine production.

Managing Risk In Biomanufacturing Managing Risk In Biomanufacturing

Commercial, manufacturing, and supply aspects in the biopharmaceutical industry can all be managed in order to mitigate risk. This white paper focuses on how a structured and transparent risk management process can be an ideal way to align the needs of patients with drug manufacturers and their suppliers, regulators, investors, and employees. Read on to learn more about guarding commercial interests, building and managing manufacturing capacity, and preventing supply disruption, and how these things can impact managing risk in biomanufacturing.

Unlocking The Potential For Efficiency In Downstream Bioprocesses

In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.

Application Note: CFS 1200™ Sealing Process
Capsugel's CFS 1200™ Liquid & Filling machine utilizes their patented LEMS® technology to create a robust and impervious seal without the need for banding. This application note describes this sealing process. Submitted by Capsugel
Accelerating Lipid-Based Drug Formulation

Formulation scientistsmust develop and validat robust systems that address the challenges posed by increasingly complex drug candidates, in ever shortening time frames.

Broaden Analysis Of Compound Factors For Predictive Solubility Solutions

Developed by the FDA, the Biopharmaceutics Classification System helps companies when they file for bioequivalence of dosage forms based on in vitro dissolution testing.

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PHARMA OUTSOURCING APP NOTES & CASE STUDIES

Ready-To-Use Fluid Management Solutions For Cross Flow Filtration Systems
A selection of fluid management components from GE Healthcare’s ReadyToProcess platform of disposable and single-use equipment was used to arrange buffer and sample management solutions for two large-scale filtration setups.
Improved Bioprocessing Measurement And Control

In this application note, three standard field service procedures for TruDO sensors are described: replacement of the membrane, refilling of the electrolyte solution, and cleaning/replacement of the cathode. 

Improvements And Flexibility In Vaccine Development And Production

The growing public awareness of a potential pandemic requiring rapid treatment of millions of healthy individuals has spurred renewed interest in vaccines. Vaccine development timelines vary from being only a fraction of other biotherapeutics to decades of research and efforts to find an effective vaccine. Vaccination campaigns mean that often very large quantities need to be manufactured, maintained, and distributed.

Expediting A Promising New Therapy With Softgel Technology

An innovative biotechnology company exploring novel therapeutics for neuroscience indications had developed a promising new chemical entity for the treatment of a severe pediatric genetic disease. However, numerous drug delivery challenges threatened the realization of the Fast Track status designation they had received due to promising early stage results. By leveraging a softgel technology, the customer was able to overcome a number of potential hurdles and expeditiously enter the Phase II/III clinical trial.

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ABOUT US

Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.

About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.

About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.

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INDUSTRY INSIGHTS

  • Sanofi Asks — Will Standardization Take End User & Supplier Relationships To The Next Level?
    Sanofi Asks — Will Standardization Take End User & Supplier Relationships To The Next Level?

    To continue the evolution of single-use technology (SUT) in biopharma, one area that must be secured is SUT supply chain reliability. Without this, a larger scale adoption of SUT may continue to be delayed as biopharmaceutical manufacturers must have access to a reliable supply chain that allows us to successfully deliver product to our customers.

  • Cost And Impact Of A Bioburden Incident
    Cost And Impact Of A Bioburden Incident

    Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.

  • Anticipating The Formulation Challenges Of Complex Molecules
    Anticipating The Formulation Challenges Of Complex Molecules

    Due to the increasing complexity of today’s API molecules, formulation problems are arising with greater frequency, delaying development, and burdening developers with unanticipated and heavy costs.

  • Choosing The Right Single-Use Bioreactor Platform
    Choosing The Right Single-Use Bioreactor Platform

    When selecting a bioreactor, you can choose stainless steel or single-use technologies, depending on your biomanufacturing requirements. The bioreactor is a key component of your bioprocessing workflow and should be regarded as a strategic asset. It is important that this core technology is carefully chosen, specified, designed, and supported, both now and in the future.

  • Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk
    Built To Fail: How Today’s Manufacturing Options Leave Pharma At Risk

    When planning for the development of a new product, a pharmaceutical manufacturer must determine very early in the process what a product’s anticipated demand will be at the time of launch. Not only is this very difficult to do, but also the consequences of incorrect forecasts can be very costly in a number of ways. Without the ability to predict capacity needs with 100% accuracy, pharma must come up with an effective way to eliminate demand risks.

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OUTSOURCING EVENTS

Clinical Study Requirements – Understanding Differences Between the US and EU July 25, 2017
1pm-2:30pm EST, Online Training
Price:  $299 - Includes Bonus Handouts!
Simplifying Your Quality System While Implementing ISO 13485:2016 Requirements – Strategies for Success July 27, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
ICH E6 Addendum R2 Team Training and Action Planning August 7, 2017
11:00am- 12:00pm EDT, Online Training
Duration:  60 Minutes
Price:  $299 - Includes Bonus Handouts!
Cell Therapy: Process Design Considerations To Support Commercialization August 9, 2017
1pm-2:30pm EDT, Online Training
Duration:  90 Minutes
Price:  $299 - Includes Bonus Handouts!
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